Events

Rappel de Siemens Dimension Vista 500 and Dimension Vista 1500 analysers

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par Siemens Healthcare Diagnostics (UK) Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    18554
  • Date de mise en oeuvre de l'événement
    2015-05-21
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • Cause
    Siemens has identified 2 issues when using dimension vista analysers with specified software versions., 1/ samples may stop processing without notification on the dimension vista 500 or dimension vista 1500. this issue is due to a failure to exchange aliquot plates, causing the lane to become unavailable., 2/ complaints were received on the dimension vista 1500 for a series of unexpected results, some of which were not flagged with errors or results that were flagged with errors. it has been determined that under a rare set of conditions, a timing issue may cause a reagent server to temporarily lose synchronization during the automatic removal of reagent cartridges from reagent server 2 to waste a container.
  • Action
    Software to be upgraded

Device

Siemens Dimension Vista 500 and Dimension Vista 1500 analysers

Manufacturer

Siemens Healthcare Diagnostics (UK) Ltd
  • Société-mère du fabricant (2017)
    Siemens AG
  • Source
    NZMMDSA